NCT03217942

Brief Summary

The purpose of this study is to investigate and determine the time course and distribution on muscle hyperalgesia and muscle pain in a repeated, low dose NGF model. It is hypothesized that low dosages i.m injections of NGF are able to induce mechanical hyperalgesia and muscle soreness in a same manner (effect of duration) as for dosages previously used in NGF studies. Furthermore, it is also speculated if several injections of low dose NGF into the muscle combined are able to course immediate pain sensation and spreading of muscle hypersensitivity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jul 2017

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 14, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

January 11, 2018

Status Verified

January 1, 2018

Enrollment Period

3 months

First QC Date

July 10, 2017

Last Update Submit

January 10, 2018

Conditions

HyperalgesiaHealthy Subjects

Keywords

Muscle sorenessNGF-induced painPain modelLong-lasting sensitization

Outcome Measures

Primary Outcomes (1)

  • Muscle sensitivity

    Pressure pain thresholds (PPTs) are assessed over the tibialis anterior muscles using a handhold pressure algometer.

    Change from baseline at 3 weeks

Secondary Outcomes (5)

  • Pressure-induced referred pain

    Change from baseline at 3 weeks

  • Activity-induced muscle soreness

    Change from baseline at 3 weeks

  • Pain intensity

    Assessed continuously at 0-5 min during the injections at each leg

  • Muscle soreness Diary

    Change from baseline at 3 weeks

  • Activity-induced muscle soreness Diary

    Change from baseline at 1 week

Study Arms (2)

Low dose

EXPERIMENTAL

All participants will receive 5 i.m injections of NGF (1 ug/0.5ml) into the tibialis anterior muscle (either left or right leg)

Drug: NGF

High dose

EXPERIMENTAL

All participants will receive 1 high dose i.m bolus injection of NGF (5 ug/0.5ml) and 4 injections of saline (control/same volume) into the tibialis anterior muscle (either left or right leg)

Drug: NGF

Interventions

NGFDRUG

Intramuscular injection

Also known as: Beta-Nerve Growth Factor, Human
High doseLow dose

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy and pain free volunteers

You may not qualify if:

  • Pregnancy
  • Drug addiction defined as the use of cannabis, opioids or other drugs
  • Previous neurologic, mental illnesses, or psychiatric diseases.
  • Past history of chronic pain in the musculoskeletal system (muscle, joint, cartilage, connective tissue)
  • Participation in other pain trials throughout the study period
  • Lack of ability to cooperate
  • Taking any analgesic 24 hours before the injections
  • Performing any strenuous leg exercise through out the study period causing sore muscles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University

Aalborg, 9220, Denmark

Location

MeSH Terms

Conditions

HyperalgesiaMyalgia

Interventions

Nerve Growth Factor

Condition Hierarchy (Ancestors)

Somatosensory DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesMusculoskeletal PainPain

Intervention Hierarchy (Ancestors)

Nerve Growth FactorsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsNerve Tissue ProteinsBiological Factors

Study Officials

  • Line Bay Sørensen, Ph.d stud.

    Aalborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double blind
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.d. stud.

Study Record Dates

First Submitted

July 10, 2017

First Posted

July 14, 2017

Study Start

July 1, 2017

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

January 11, 2018

Record last verified: 2018-01

Locations

DK(1)